Block Duration After Spinal Block and iv Dexamethasone.

• Sponsor: Eric Albrecht (Other)
• Overall Status: Completed
• CT.gov ID: NCT03527576
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 47
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

It has been largely demonstrated that iv dexamethasone prolongs the duration of analgesia after peripheral nerve block. However, data are missing regarding the duration of analgesia after spinal block. The objective of this randomized controlled double-blinded trial is to assess whether intravenous dexamethasone administered after a spinal block, before the surgery would prolong sensory block characteristics without impacting the motor block duration.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Lower Limb Injury	Drug: Dexamethasone; Drug: NaCl 0.0308 MEQ/ML Injectable Solution	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Nov 1, 2021
• Actual Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexamethasone Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.	Drug: Dexamethasone; Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
Placebo Comparator: Placebo Intravenous injection of NaCl 0,9% before the surgery.	Drug: NaCl 0.0308 MEQ/ML Injectable Solution; Intravenous injection of NaCl 0.9% before the surgery.

Outcome Measures

Primary Outcome Measures

1. Duration of sensory block (minutes) [Postoperative day 0]

   Time interval between injection of the local anaesthetic and the regression of 2 dermatoma, compared to the highest dermatoma reached

Secondary Outcome Measures

1. Highest dermatoma reached (level) [Postoperative day 0]

2. Onset time between injection and highest dermatoma (minutes) [Postoperative day 0]

3. Total duration of the sensory block (minutes) [Postoperative day 0]

4. Total duration of the motor block (minutes) [Postoperative day 0]

5. Time to the first analgesic request (minutes) [Postoperative day 0]

6. Cumulative consumption of morphine (mg) [Postoperative days 0, 1 and 2]

7. Pain score [Postoperative days 0, 1 and 2]

   Numeric rating scale (0-10)

8. Rate of postoperative nausea and vomiting [Postoperative day 0, 1 and 2]

   YES/NO

9. Rate of pruritus [Postoperative day 0, 1 and 2]

   YES/NO

10. Rate of urinary retention [Postoperative day 1 and 2]

    YES/NO

11. Satisfaction level [Postoperative day 2]

    Numeric rating scale (0-10)

12. Length of stay [up to 14 days]

    Days

13. Persistent pain [3 and 6 postoperative months]

    YES/NO

14. Pain score if persistent pain [3 and 6 postoperative months]

    Numeric rating scale (0-10)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient with ASA I-III status ;

• Patient scheduled for an osteosynthesis surgy of the lower limb

Exclusion Criteria:

• Polytrauma patient

• Pregnancy

• Contraindication to spinal anesthesia

• Contraindication to dexamethasone administration

• Patient with chronic pain

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire Vaudois and University of Lausanne	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

• Eric Albrecht

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric Albrecht, Program director of regional anaesthesia, Centre Hospitalier Universitaire Vaudois
• ClinicalTrials.gov Identifier: NCT03527576
• Other Study ID Numbers: CER 2018-00500
• First Posted: May 17, 2018
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Leg Injuries; Dexamethasone

Study Results

No Results Posted as of Jul 20, 2022